TransCelerate
Quality Management
System Initiative:
Clinical Knowledge Management
TOPICS
Knowledge Management (KM) as an
Enabling Element of a Clinical Quality
Management System (QMS)
01
Clinical Knowledge Management Basics
02
Designing, Implementing, and Sustaining a
Clinical Knowledge Management Program
03
Clinical Knowledge Management Tools
04
CKM Detailed Overview
Approved for Use August 2016
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
2
01
Knowledge
Management is an
Enabling Element of
a Clinical QMS
Why Is TransCelerate Addressing Clinical
Knowledge Management?
Understand
the Context
Leadership Commitment
to Quality
Organizational
Commitment to Quality
Continual Improvement
of the Framework
CULTURE OF QUALITY
Processes
Resources, Roles & Responsibilities
Partnering
Risk Management
Issue Management
Knowledge Management
Documentation Supporting Achievement of Quality
Management Review
Elements of a Clinical QMS Conceptual Framework
Assessing the CQMS
TransCelerate Member
Company interviews and
discussions with regulators on
the effective elements of a
Clinical QMS identified
Knowledge Management as
an area of interest and
potential improvement
Foundational Aspects
In a recent anonymous survey of 152 individuals across Clinical Development / Quality
organizations in TransCelerate Member Companies:
 Only 10 % of participants believe their organizations have a high or comprehensive understanding of
Knowledge Management. Approximately 50% believe there is some understanding and almost 40% believe
their organization have little to no understanding.
 Over 75% of participants indicated that improvements in sharing and searching for knowledge within their
Clinical Development organization would have a high to very high positive impact in each of the following
ways: Saving time, avoiding “re-inventing the wheel”, and enabling timely and accurate decision making.
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
4
A Practical Definition and Value of Knowledge
Management for Clinical Development
Clinical QMS Conceptual
Framework Concept Paper
“Strategies and processes designed to
identify, capture, structure, value,
leverage, and share an organization’s
intellectual assets to enhance the
clinical development organization’s
performance and the performance of
QMS elements, including issue
management and risk management,
based on two critical activities:
“Getting the right information to
the right people at the right time”
Value
Connects people with information
and experts more rapidly
Reduces unnecessary or redundant
re-work across teams/functions
1. Capture, storage and accessibility of
institutional explicit and tacit
knowledge, and
Retains and facilitates sharing of
critical knowledge
2. Its assimilation, interpretation,
dissemination, application and
maintenance within an organization”
Enables searching, finding and
applying information faster
Enhances decision making
Adapted from The Business Dictionary:
http://www.businessdictionary.com/definition/knowledge-management.html)
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
5
Examples of KM in Action- What “Good” Looks
Like
When KM is in practice, people across an organization will…
Know what knowledge
exists, where to look for
it and how to quickly
find it
Capture knowledge
in a consistent and
searchable manner
Know who the experts
are and how to
contact them for
advice
Share lessons learned
so new work always
starts using current best
practice
Connect readily across
boundaries of teams,
functions and
geographies
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
QMS 5 May 2016
6
Insert Relevant Case Scenarios
A number of Clinical KM scenarios have been developed
and can be inserted here (or relevant scenarios from your
own company) to help demonstrate common challenges
and the value of implementing a Clinical KM Program.
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
7
02
Clinical Knowledge
Management Basics
Transformation of Data into Knowledge
Knowledge…
Is know-how, understanding, experience, insight,
intuition, contextualized information
Information…
Is data that has been contextualized,
categorized, calculated and condensed
Data…
Facts and figures which relay
something specific, but which
are not organized
Source: http://www.knowledge-management-tools.net/knowledge-information-data.html
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
9
Difference between Explicit and Tacit
Knowledge
EXPLICIT
KNOWLEDGE
TACIT
KNOWLEDGE
Captured and Documented
Experience and Insight
Examples:
• Protocols and Study Reports
• Submission Summary Documents
• Response to Agency Queries
• SOPs, Regulations, Guidances
Hard to document and measure, in the
minds of people and/or shared by
personal connection.
Examples:
Experience and insights acquired through
lessons learned from
–
Clinical program execution
–
Internal audits and regulatory inspections
–
Partnering engagements
–
Application of SOPs in real-life situations
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
10
TransCelerate’s Knowledge Management
Framework
Knowledge Management
1
People
2
• KM Specific roles
• Integration of
KM in business
processes
• Training,
teaching,
mentoring
• Governance
• Change
management
roles
5
6
Business
Process
• Measurement
• Change
management
3
Content
• Tacit & explicit
knowledge
• Taxonomy &
metadata
• Templates &
tools
4
Technology
• Data Storage
• Document
repositories
• Team sites
• Networking
software
• Search
capabilities
Continuous
Improvement
• Flexibility
• Knowledge-driven learning and improvement
Culture
• Leadership commitment
• Promotes knowledge seeking and exchange
Adapted from O’Dell and Hubert, 2011.
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
QMS 5 May 2016
11
People
Knowledge Management
1
6
Business
Process
3
Content
•
KM Specific
roles
•
•
•
Training,
teaching,
mentoring
Integration of
KM in business
processes
Tacit &
explicit
knowledge
•
Governance
•
•
Measurement
Taxonomy &
metadata
•
Change
management
•
Templates &
tools
•
5
2
People
Change
management
roles
Continuous
Improvement
•
•
Flexibility
Knowledge-driven learning and improvement
Culture
•
•
Leadership commitment
Promotes knowledge seeking and exchange
4
Technology
•
Data Storage
•
Document
repositories
•
Team sites
•
Networking
software
•
Search
capabilities
Key Roles
• Clinical KM
Champion
• Change Agents
• Executive Sponsor
• Clinical KM
Group/Individual
• Governance
body
• Subject Matter
Experts
Highlights
Individuals embrace the KM behaviors
of seeking and sharing knowledge and
collaborating across functional areas
and geographical boundaries.
People engagement in and use of
Clinical KM is directly related to
company culture.
Depending on the size of the
organization, these roles may be served
by the same person, multiple people,
shared or outsourced.
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
12
Business Process
Knowledge Management
1
6
Business
Process
•
KM Specific
roles
•
•
Training,
teaching,
mentoring
•
5
2
People
Change
management
roles
3
Content
Integration of
KM in business
processes
•
Tacit &
explicit
knowledge
•
Governance
•
•
Measurement
Taxonomy &
metadata
•
Change
management
•
Templates &
tools
Continuous
Improvement
•
•
Flexibility
Knowledge-driven learning and improvement
Culture
•
•
Leadership commitment
Promotes knowledge seeking and exchange
4
Technology
•
Data Storage
•
Document
repositories
•
Team sites
•
Networking
software
•
Search
capabilities
Key Roles
• Integration of KM in business processes
• Governance
• Measurement
• Change Management
Highlights
KM approaches should be integrated
into clinical development business
processes.
KM Business Processes enable oversight
of the Clinical KM Program and support
meeting its goals at different stages of
Clinical KM development and maturity:
»
»
»
»
Core KM Processes
Governance
Measurement Approach
Change Management
A comprehensive communication plan
with targeted messaging for sponsors
and stakeholders during development,
implementation, and ongoing use of
the Clinical KM Program.
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
13
Content
Knowledge Management
1
5
6
2
People
Business
Process
3
Content
•
KM Specific
roles
•
•
•
Training,
teaching,
mentoring
Integration of
KM in business
processes
Tacit &
explicit
knowledge
•
Governance
•
•
Change
management
roles
•
Measurement
Taxonomy &
metadata
•
Change
management
•
Templates &
tools
Continuous
Improvement
•
•
Flexibility
Knowledge-driven learning and improvement
Culture
•
•
Leadership commitment
Promotes knowledge seeking and exchange
4
Technology
•
Data Storage
•
Document
repositories
•
Team sites
•
Networking
software
•
Search
capabilities
Approaches for Organizing
& Managing Content
Business rules for where to store and
how to categorize content for
successful search and retrieval.
» Review of taxonomy categories for suitability for
changing needs and consistency across relevant
business areas
• Tacit & explicit knowledge
Validation of the content on initial
capture and assurance that the
content remains current.
• Taxonomy & metadata
Archival of out-of-date content.
Key Content
• Templates & tools
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
14
Technology
Knowledge Management
1
6
Business
Process
3
Content
•
KM Specific
roles
•
•
•
Training,
teaching,
mentoring
Integration of
KM in business
processes
Tacit &
explicit
knowledge
•
Governance
•
•
Measurement
Taxonomy &
metadata
•
Change
management
•
Templates &
tools
•
5
2
People
Change
management
roles
Continuous
Improvement
•
•
Flexibility
Knowledge-driven learning and improvement
Culture
•
•
Leadership commitment
Promotes knowledge seeking and exchange
Example Capabilities
4
Technology
•
Data Storage
•
Document
repositories
•
Team sites
•
Networking
software
•
Search
capabilities
Highlights
Technology should support the Clinical
KM program, strategy, and selected
approaches.
Technology can:
»
»
»
»
Bridge geographies and people
Enable real-time and rapid access
Simplify complex multiple sources of information
Be fit-for-purpose and fit within existing business
processes
• Data storage
• Document repositories
• Team sites
• Networking software
• Search capabilities
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
15
Continuous Improvement
Knowledge Management
1
6
Business
Process
3
Content
•
KM Specific
roles
•
•
•
Training,
teaching,
mentoring
Integration of
KM in business
processes
Tacit &
explicit
knowledge
•
Governance
•
•
Measurement
Taxonomy &
metadata
•
Change
management
•
Templates &
tools
•
5
2
People
Change
management
roles
Continuous
Improvement
•
•
Flexibility
Knowledge-driven learning and improvement
Culture
•
•
Leadership commitment
Promotes knowledge seeking and exchange
4
Technology
•
Data Storage
•
Document
repositories
•
Team sites
•
Networking
software
•
Search
capabilities
Key Points
Initially, the Clinical KM program and
strategy will be designed to meet current
organizational needs. A roadmap will
guide its evolution.
It should evolve to meet changing
demands of the business in response to
internal and external influences.
Maturity Model
Level 5
INNOVATE
Continuously
improving
practices
Scalable
Knowledge
Level 4
OPTIMIIZE
Level 3
STANDARDIZE
Level 2
DEVELOP
Level 1
INITIATE
Measure and
adaptive
Common
processes and
approaches
Localized and
repeatable
practices
Enable
Knowledge
Applied
Knowledge
Ad hoc
Knowledge
Growing
Awareness
Source: APQC’s Level of Knowledge Management Maturity.
Reproduced with permission
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
16
Culture
Knowledge Management
1
6
Business
Process
3
Content
•
KM Specific
roles
•
•
•
Training,
teaching,
mentoring
Integration of
KM in business
processes
Tacit &
explicit
knowledge
•
Governance
•
•
Measurement
Taxonomy &
metadata
•
Change
management
•
Templates &
tools
•
5
2
People
Change
management
roles
Continuous
Improvement
•
•
Flexibility
Knowledge-driven learning and improvement
Culture
•
•
Leadership commitment
Promotes knowledge seeking and exchange
4
Technology
•
Data Storage
•
Document
repositories
•
Team sites
•
Networking
software
•
Search
capabilities
Key Points
An organizational culture of seeking and
sharing knowledge is critical to the success
of a Clinical KM Program.
High dependency on the behavior of both
individuals and the clinical development
organization as a whole.
Enabling Behaviors
• Actively seeking and sharing knowledge
• Using existing knowledge in a proactive
manner
• Openly communicating and
collaborating across boundaries and
focusing on the collective goal rather
than individual roles or functions
• Considering all questions valuable
• Considering both positive and negative
outcomes as sources of valuable
knowledge
• Viewing time spent seeking, sharing, and
capturing knowledge as a value-added
activity that is a routine part of job roles
• Promoting continuous learning and
collaboration
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
17
03
Designing,
Implementing, and
Sustaining a Clinical
KM Program
Considerations for Implementation of a Knowledge
Management Framework Tailored to a Clinical
Development Organization
Think big, start small. And most importantly – Start!
Understand the
Knowledge Needs
Identify the critical knowledge
necessary to drive optimal
outcomes tailored to
organizational needs
Improve and Sustain
Assess performance against
anticipated outcomes and
adjust as necessary. Assess
opportunities for continuous
improvement to sustain the
framework over time.
Assess Opportunity
1
4
2
3
Understand where improvement
of knowledge flow may provide
opportunity for enhanced
execution to improve critical
business outcomes
Design and Implement
Solutions
Define and deploy
mechanisms to enable
and improve knowledge
access and sharing
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
19
Step 1: Understand the Knowledge Needs
1
Understand the
Knowledge
Needs
Improve
and Sustain
4
2
Actions to Take:
Assess
Opportunity
3
Design and
Implement
Solutions
1. Identify most critical information
and knowledge needed by the
organization
2. Understand the challenges and
risks related to knowledge gaps
3. Assess KM behaviors of the
organization
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
20
Step 2: Assess Opportunities
1
Understand the
Knowledge
Needs
Improve
and Sustain
4
2
Actions to Take:
Assess
Opportunity
3
Design and
Implement
Solutions
1. Identify current gaps in the
availability of specific knowledge
needed to support key business
processes
2. Prioritize opportunities based on
business needs
3. Propose business case and pilot
projects to relevant governance
body for approval
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
21
Step 3: Design and Implement
1
Understand the
Knowledge
Needs
Improve
and Sustain
4
2
Actions to Take:
Assess
Opportunity
3
Design and
Implement
Solutions
1.
Select relevant KM approach(es) to
address the types of knowledge to be
managed
2.
Design Clinical KM solutions/tools
3.
Develop training plan and training
materials
4.
Communicate training and
implementation plans to users
5.
Deliver training to users
6.
Deploy Clinical KM solutions/tools
7.
Support users
8.
Define measures for assessing use and
effectiveness
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
22
Step 4: Improve and Sustain
1
Understand the
Knowledge
Needs
Improve
and Sustain
4
2
Actions to Take:
Assess
Opportunity
3
Design and
Implement
Solutions
1. Establish ongoing oversight and
business processes for Clinical KM
Program maintenance and
improvement
2. Update and/or expand Clinical
KM Strategy and Program based
on evolving business needs
3. Define and implement businessrelated measures for assessment
of Clinical KM performance
4. Develop approaches for
reinforcement and recognition of
Clinical KM successes
Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved.
23
Key Messages
Common approaches that enable sharing of and searching for knowledge across
organizational and geographic boundaries facilitate consistent quality of execution,
enhanced efficiency, and continual improvement of business processes.
A knowledge seeking and sharing culture coupled with supporting business processes
and people are critical for the successful integration of KM approaches into routine
work.
The development of a Clinical KM Program begins with obtaining Senior Leadership
sponsorship and engaging the clinical development organization on the potential
benefits of KM.
Start with prioritizing KM needs and a narrow focus on a pilot project with a vision to
expand based on demonstrated value.
As part of the ongoing support and continual improvement of the Clinical KM program,
the value of KM should be measured, realizing that success will mean different things at
different stages of Clinical KM development and maturity.
Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved.
24
THANK YOU
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